Fecal incontinence typically is a source of physical discomfort and the cause of social and personal debilitation. It is most likely to affect the aged or individuals suffering from neurological trauma. However, abnormalities in stool volume or consistency, colonic transit, anal sphincter function, anorectal sensation, or anorectal reflexes also may result in incontinence. Madoff, et al., New Eng. J. Med., 326: 1002-1007 (1992). Finally, a significant number of incontinence cases involve post-partum pelvic neuropathies, and thus may affect women at a relatively young age. Many of these women develop loose pelvic floor muscles and a more flaccid recto-vaginal septum.
Mild cases of fecal incontinence typically are treated by instituting dietary changes. Biofeedback therapies also have been proposed in which a balloon, inserted in the rectum, provides a sensation similar to that of stool immediately prior to voiding. The patient is trained to perceive differing volumes of distention in the balloon and to respond accordingly by contracting and relaxing the anal sphincter muscles. See, e.g., Cerulli, et al., Gastroenterology, 76: 742-746 (1979).
Surgical remedies for severe cases of fecal incontinence include sphincter repair, placation of the posterior sphincter, anal encirelement in which a metal or elastic band mechanically tightens the anus, and muscle transfer procedures. Each of these techniques attempts to create a passive barrier to stool. However, they typically produce poor results, including leakage of stool, infection, and fecal impaction.
Recently, it has been proposed that fecal incontinence that cannot be corrected by surgery or by other approaches may be treated by insertion into the rectum of an artificial anal sphincter consisting of an inflatable cuff. Christiansen, et al., Dis. Colon Rectum, 32: 432-436 (1989). The cuff may be manually controlled in order to regulate passage of stool. Still other devices for control of fecal incontinence have been proposed. For example, U.S. Pat. No. 4,850,986 reports a fecal incontinence device that includes a tube inserted in the rectum and held by an adhesive or a clip to the thigh. Fecal incontinence bags have also been reported as a means of collecting voided stool. Such bags generally include a portion that is inserted in the rectum and connected to a disposable collection bag. See, e.g., U.S. Pat. No. 4,917,692.
A problem with such non-surgical devices for controlling fecal incontinence is that they are intrusive and often make walking, sitting, and other activities difficult. Moreover, such devices are not easily controlled in order to allow voiding of stool when desired by the patient. Accordingly, there is a need in the art for means for controlling fecal incontinence that is convenient, relatively non-intrusive on daily physical activity, and easy to regulate and manipulate during use. Such means are provided by the present invention.